laboratory sterility test kits ISO9001 AS base 0.45μm membrance for laboratory

What is a sterility test?

In the production of biopharmaceuticals, contaminating microorganisms can enter the process at many stages. When introduced, bacteria or fungi can grow and cause serious damage to the final product. Over time, the presence of microorganisms in vaccines and other biopharmaceuticals can damage the product and pose a significant risk to the patient's health. As a result, regulatory agencies, including the FDA (1) and EMA (2), are conducting rigorous tests to ensure that no pollution has occurred. This is determined by performing a sterility test on a representative sample to identify the presence of viable microorganisms in the material. Sterility certification is part of the documentation required for many biopharmaceuticals.

Features

•  Ultrasonic welding process ensures tightness and pressure resistance;
•  100% passed the airtight performance test;

•  Microbial retention, microbial growth (sensitivity) and sterility testing ensure that the results

•  ultrasonic welding process, the welding is flat and firm, to achieve the best sealing performance.
•  High-elastic pump tube manufactured by special materials, with long-lasting tension, wear-resisting and anti-pressure, can ensure the maximum inspection volume is successfully completed.
•  Assembly fixtures for pipes are easier to use.

parameter

 

Schematic Diagram	Model	Inspection Style	Packing Spe.
	Py220C	Glass Bottle Large Volume Injection	72Sets/Box 18sets/Box   48 Sets/Box 12sets/Box
	Py330C
	Ksf220C	Glass Bottle Large-Capacity Antibiotic Injection
	Ksf330C
	Apy220C	Ampoule Injection
	Apy330C
	Kapy220C	Ampoule Antibiotic Injection
	Kapy330C
	Dgb220C	Vial Bottle Soluble Powder
	Dgb330C
	Kdgb220C	Vial Bottle Soluble Antibiotic Powder
	Kdgb330C
	Sdy220C	Soft Bag Large Volume Injection
	Sdy330C
	Fsy220C	Insoluble Liquid
	Fsy330C
	Nkf220C	Powder That Needs To Be Dissolved And Diluted
	Nkf330C

 

 

Features

• Ultrasonic welding process, the welding is smooth and sturdy, to achieve the best sealing performance.
• The elastic high-elastic pump tube is made of special materials and has long-term durability, wear resistance and pressure resistance to ensure complete detection.
• Imported medical dialysis packages from the United States can be used to rapidly degrade ethylene oxide and reduce ethylene oxide residues to ensure product sterility.
• The elastic high-elastic pump tube is made of special materials and has long-term durability, wear resistance and pressure resistance to ensure complete detection.
• Transparent blister packs conform to international standards.
• Transparent composite packaging to reduce packaging waste and reflect environmental protection
• Imported medical dialysis packages from the United States can be used to rapidly degrade ethylene oxide and reduce ethylene oxide residues to ensure product sterility.
• Microbial microbial retention, microbial growth (sensitivity) and sterility testing ensure reliable and reliable results of sterility testing.
• Filter: bubble point method, bacterial retention test.
• Chewing stability test: The culture period is 14 days.

Sterility testing is an extremely important step before the release of sterile products. False positive, false negative experimental results, as well as experimental equipment failures and human error will bring significant time and money losses to the customer and directly affect the final release of the product. The YT series of bacteria collection equipment and the collection of sterile culture equipment provide a perfect solution. The test samples of different packaging forms are safely and uniformly transferred to the collecting culture incubator by the peristaltic pump of the collecting instrument, so that the sterility test results are more consistent and reliable.